PURPOSE: Lifitegrast ophthalmic solution, 5.0%, is an anti-inflammatory agent indicated for the treatment of signs and symptoms of dry eye disease. This post hoc analysis of phase 3 pivotal data identified patients with rapid and pronounced reduction in dry eye symptoms with lifitegrast treatment and evaluated defining characteristics.

METHODS: This was an exploratory analysis of data from the OPUS-2 and OPUS-3 studies (NCT01743729, NCT02284516): 12-week, prospective, double-masked, multicenter, placebo-controlled, randomized, parallel-arm clinical trials. Pooled data in the lifitegrast treatment arm were analyzed using a cluster analysis to identify homogenous populations of patient response types based on percent change from baseline in eye dryness score (EDS; as evaluated on a VAS 0-100 scale) at Days 14, 42, and 84. Patients with Sjögren's syndrome or incomplete data were excluded from the analysis. Patient demographics and baseline characteristics among the defined subgroups were evaluated.

RESULTS: The analysis population included 638 patients in the lifitegrast treatment arm. Mean (SD) age was 58.4 (14.1) years; 77.4% were female; 80.1% were White, 10.3% Black, and 6.0% Asian. At baseline, mean (SD) EDS score was 69.4 (16.9), overall. Five patient subgroups were identified in the lifitegrast treatment arm: early sustained responders with ≥60% EDS reduction at all time points (n=113; 17.7%); steady responders with ≥20%, ≥40%, and ≥60% reduction at Days 14, 42, and 85 (n=113; 17.7%); Day 84 response of ≥60% (n=127; 19.9%); Day 84 response of ≤30% to <60% n="119;" 18.7 day 84 response of><30% n="166;" 26.0. there were significant differences in mean symptom scores across the 5 patient subgroups p><0.001), with numerically lower mean symptom scores for eye pain burning stinging foreign body sensation and photophobia in the patients demonstrating an early sustained response.>

CONCLUSION: The majority (353 of 638, 55.3%) of patients treated with lifitegrast had ≥60% reduction in EDS by Day 84. The group with rapid and sustained EDS reductions by week 2 tended to have lower symptom scores than the other subgroups, suggesting that early treatment may be beneficial for maximal response. Further studies to corroborate these findings are warranted.